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PRESIDENTIAL AIDS ADVISORY PANEL REPORT PDF

134 Pages·2001·1.06 MB·English
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P RESIDENTIAL AIDS A P DVISORY ANEL R EPORT A synthesis report of the deliberations by the panel of experts invited by the President of the Republic of South Africa, the Honourable Mr Thabo Mbeki March 2001 Contents CONTENTS.....................................................................................................................2 ACKNOWLEDGEMENTS...................................................................................................7 ABBREVIATIONS............................................................................................................8 CHAPTER 1 – SETTING THE SCENE..................................................................................9 1.1 BACKGROUND.............................................................................................................................9 1.2 COMPOSITION OF THE PRESIDENTIAL AIDS ADVISORY PANEL............................................................10 1.3 TERMS OF REFERENCE FOR THE PRESIDENTIAL AIDS ADVISORY PANEL................................................11 1.4 THE REPORT.............................................................................................................................13 CHAPTER 2 - AETIOLOGY AND TRANSMISSION OF AIDS................................................15 2.1 INTRODUCTION.........................................................................................................................15 2.2 DOES HIV CAUSE AIDS?............................................................................................................16 2.2.1 Visualisation and Isolation of the Virus..........................................................................16 2.2.2 PCR (Polymerase Chain Reaction) and ELISAs...............................................................18 2.2.3 Clinical and Laboratory Evidence of Causation...............................................................19 2.2.4 Evidence from Animal Models........................................................................................22 2.2.5 Epidemiological Evidence..............................................................................................22 2.3 ALTERNATIVE HYPOTHESIS ON THE CAUSE OF AIDS..........................................................................23 2.3.1 The Chemical AIDS Hypothesis......................................................................................23 2.3.2 The Immunotoxicological Hypothesis.............................................................................24 2.3.3 The Oxidation Hypothesis..............................................................................................24 2.4 THE INVOLVEMENT OF COFACTORS (OR RISK FACTORS) IN AIDS.........................................................24 2.4.1 Involvement of cofactors in HIV-causes-AIDS Hypothesis..............................................25 2.4.2 Risk factors that are the primary cause of AIDS according to alternative hypotheses/theories......................................................................................................27 2.5 TRANSMISSION OF HIV AND AIDS...............................................................................................28 2.5.1 HIV Transmission as Estimated from ‘AIDS Deaths.’......................................................29 2.5.2 Sexual Transmission......................................................................................................30 2.5.3 Mother-to-Child Transmission........................................................................................32 2.5.4 Blood-borne transmission and Occupational Exposure...................................................33 2.5.5 Epidemiology of Transmission.......................................................................................34 CHAPTER 3 – SURVEILLANCE........................................................................................37 3.1 WHAT ARE THE QUESTIONS AND ISSUES?.......................................................................................37 2 Presidential Aids Advisory Panel Report 3.2 OVERVIEW ON THE NECESSITY FOR SURVEILLANCE............................................................................37 3.3 SOUTH AFRICAN EPIDEMIC – FACT OR FICTION................................................................................38 3.3.1 AIDS mortality...............................................................................................................39 3.4 EPIDEMIOLOGICAL THEORY OF CAUSAL INFERENCE...........................................................................41 3.5 SOCIO-ECONOMIC RISK FACTORS..................................................................................................42 3.6 DIFFERENCES IN THE AFRICAN EPIDEMIC, COMPARED WITH EUROPE AND THE USA.................................43 3.7 THE ROLE OF MATHEMATICAL MODELS IN FORECASTING THE EPIDEMIC..................................................44 3.8 SURVEILLANCE RECOMMENDATIONS – WHAT SHOULD BE DONE ABOUT THE SOUTH AFRICAN EPIDEMIC?.......45 3.8.1 Deliberations of the panel.............................................................................................45 RECOMMENDATION..............................................................................................................................45 3.8.2 Discussion on mortality data.........................................................................................45 RECOMMENDATION..............................................................................................................................45 3.8.3 Recommendations from panellists who do not subscribe to the causal linkage between HIV and AIDS................................................................................................................45 3.8.4 Recommendations from panellists who subscribe to HIV as the cause of AIDS..............46 3.8.5 General recommendation..............................................................................................48 CHAPTER 4 - HIV TESTS AND THEIR ACCURACY............................................................49 4.1 HIV TESTING...........................................................................................................................49 4.1.1 ELISA test....................................................................................................................50 4.1.2 Western Blot.................................................................................................................51 4.1.3 PCR test for viral load...................................................................................................52 4.1.4 CD4 count.....................................................................................................................53 4.2 VIRUS ISOLATION OR CO-CULTURING.............................................................................................53 4.3 MORATORIUM ON HIV TESTING...................................................................................................53 4.4 RECOMMENDATIONS ON HIV TESTING...........................................................................................54 4.4.1 Proposed studies and experiments................................................................................54 4.4.2 Recommendation on future HIV testing.........................................................................55 4.4.3 General recommendations on testing............................................................................55 CHAPTER 5 –THE TREATMENT OF AIDS AND THE USE OF ANTI-RETROVIRAL DRUGS......56 5.1 INTRODUCTION.........................................................................................................................56 5.2 EVIDENCE IN SUPPORT OF THE USE OF ANTI-RETROVIRAL DRUGS.........................................................56 5.3 EVIDENCE AGAINST THE USE OF ANTI-RETROVIRAL DRUGS..................................................................57 5.4 RECOMMENDATIONS ON TREATMENT WITH ANTI-RETROVIRAL DRUG.....................................................59 5.4.1 Recommendations on the use of anti-retroviral drugs from the group opposed to their use................................................................................................................................59 5.4.2 Recommendations from the proponents of anti-retroviral drug use................................60 RECOMMENDATIONS:...........................................................................................................................61 CHAPTER 6: PREVENTIVE AND PROPHYLACTIC MEASURES AGAINST AIDS...................63 3 Presidential Aids Advisory Panel Report 6.1 PREVENTION OF AIDS FROM THE POINT OF VIEW OF PANELLISTS WHO DO NOT SUPPORT THE CAUSAL LINK BETWEEN HIV AND AIDS..........................................................................................................64 6.1.1 Recommendations.........................................................................................................64 6.2 PREVENTION OF AIDS FROM THE POINT OF VIEW OF PANELLISTS WHO SUPPORT THE CAUSAL LINK OF HIV TO AIDS....................................................................................................................................65 6.2.1 General recommendations.............................................................................................66 6.2.2 Recommendations on prevention of HIV/AIDS through sexual transmission..................66 6.2.3 Recommendations on prevention of blood-borne transmission of HIV/AIDS...................67 6.2.4 Recommendations on prevention of mother-to-child transmission of HIV......................67 6.3 PROPHYLAXIS AGAINST OPPORTUNISTIC INFECTIONS.........................................................................69 6.3.1 Introduction..................................................................................................................69 6.3.2 Opportunistic infections.................................................................................................70 CHAPTER 7 – SOCIO--ECONOMIC FACTORS IN THE CONTEXT OF HIV/AIDS....................72 7.1 MALNUTRITION AND SANITATION..................................................................................................72 7.2 ORPHANS................................................................................................................................73 7.3 ETHICS AND HUMAN RIGHTS........................................................................................................73 7.3.1 Ethics............................................................................................................................73 7.3.2 Human rights................................................................................................................73 7.4 SEXUAL BEHAVIOUR...................................................................................................................74 7.4.1 Rape.............................................................................................................................74 7.4.2 Stigmatisation...............................................................................................................74 7.4.3 Promiscuity...................................................................................................................75 7.4.4 Condom use..................................................................................................................75 7.4.5 Issues of economics......................................................................................................76 7.5 VACCINE DEVELOPMENT..............................................................................................................76 7.6 SUMMARY AND RECOMMENDATIONS...............................................................................................76 CHAPTER 8: RECOMMENDATIONS...............................................................................78 8.1 INTRODUCTION.........................................................................................................................78 8.2 RECOMMENDATIONS ON SURVEILLANCE – WHAT SHOULD BE DONE ABOUT THE SOUTH AFRICAN EPIDEMIC?..78 8.2.1 Deliberations of the panel.............................................................................................78 RECOMMENDATION..............................................................................................................................78 8.2.2 Discussions on mortality data........................................................................................78 RECOMMENDATION..............................................................................................................................78 8.2.3 Recommendations from panellists who do not subscribe to the causal linkage between HIV and AIDS................................................................................................................79 8.2.4 RECOMMENDATIONS FROM PANELLISTS WHO SUBSCRIBE TO HIV AS THE CAUSE OF AIDS.........................79 8.2.5 General recommendation..............................................................................................81 8.3 RECOMMENDATIONS ON HIV TESTING...........................................................................................81 4 Presidential Aids Advisory Panel Report 8.3.1 Proposed studies and experiments................................................................................81 8.3.2 Recommendation on future HIV testing.........................................................................82 8.3.3 General recommendations on testing............................................................................82 8.4 RECOMMENDATIONS ON TREATMENT OF AIDS WITH ANTI-RETROVIRAL DRUG........................................82 8.4.1 Recommendations on the use of anti-retroviral drugs for the treatment of AIDS from the panellists opposed the causal link between HIV and AIDS.............................................82 8.4.2 Recommendations on the treatment of AIDS from the proponents of anti-retroviral drug use................................................................................................................................83 8.5 RECOMMENDATIONS ON PREVENTION OF AIDS................................................................................86 8.5.1 Recommendations on prevention of AIDS from the point of view of panellists who do not support the causal link between HIV and AIDS..............................................................86 8.5.2 Recommendations on prevention of AIDS from the point of view of panellists who support the causal link of HIV to AIDS..........................................................................87 8.6 RECOMMENDATIONS ON SOCIO-ECONOMIC FACTORS THAT IMPACT ON AIDS..........................................91 CHAPTER 9: PROPOSED RESEARCH PROJECTS AND STUDIES.......................................92 9.1 GENERAL RECOMMENDATIONS ON RESEARCH...................................................................................92 9.2 PROPOSAL 1: QUALITY ASSESSMENT OF HIV TESTING: ESTABLISHING A BASELINE AND VALIDATING HIV ELISA TESTING IN SOUTH AFRICA...............................................................................................92 9.2.1 Rationale.......................................................................................................................92 9.2.2 Establishing a Baseline: Quality Assessment of HIV Testing of five independent sites in South Africa..................................................................................................................93 9.3 PROPOSAL 2: DETERMINATION OF THE ROBUSTNESS OF THE CURRENT HIV ELISA TESTS THAT ARE BEING USED IN SOUTH AFRICA.............................................................................................................94 9.3.1 Purpose of experiment..................................................................................................94 9.3.2 Methodology.................................................................................................................94 9.4 PROPOSAL 3: MOLECULAR BEACONS.............................................................................................95 9.5 PROPOSAL 4: DO MOST PEOPLE WITH HIV INFECTION SHOW SIGNS OF AIDS WITHIN FIVE (5) TO TEN (10) YEARS?..................................................................................................................................95 9.6 PROPOSAL 5: PREADSORPTION AND VIRUS ISOLATION EXPERIMENTS - THE NEED FOR A GOLD STANDARD IN THE DIAGNOSIS OF HIV INFECTION..............................................................................................95 9.6.1 Importance of the Proposed HIV Experiments...............................................................96 9.6.2 Principles of the Proposed Experiments.........................................................................98 9.7 PROPOSAL 6: QUESTIONABLE AFRICAN AIDS /HIV STATISTICS - EPIDEMIOLOGY................................100 9.8 PROPOSAL 7: PROPOSED INVESTIGATION OF THE DIAGNOSIS OF HIV/AIDS........................................100 9.8.1 Current procedure.......................................................................................................100 9.8.2 Investigation of reliability of serological tests for HIV.................................................101 9.8.3 Extensions.................................................................................................................102 9.8.4 Interpretation of findings............................................................................................102 5 Presidential Aids Advisory Panel Report 9.9 PROPOSAL 8: STUDY TO FIND OUT THE REAL MEANING OF HIV TESTS...............................................103 9.10 PROPOSAL 9: TO TEST THE RELIABILITY OF ONE OF THE MAIN LABORATORY METHODS CURRENTLY USED TO QUANTIFY HIV IN THE BLOOD OF SEROPOSITIVE INDIVIDUALS - USING THE ELECTRON MICROSCOPE.......104 9.10.1AIM OF THE EXPERIMENTS.........................................................................................................104 9.10.2MATERIALS AND METHODS........................................................................................................104 9.10.3TECHNICAL ASSISTANCE NEEDED:...............................................................................................105 9.11 PROPOSAL 10: TO DETERMINE WHICH IS MORE HARMFUL - HIV OR ANTI HIV DRUGS?.........................106 CHAPTER 10: CONCLUSION.........................................................................................107 APPENDIX 1................................................................................................................109 INTERNET DISCUSSION OF THE PRESIDENTIAL AIDS REVIEW PANEL....................................................109 APPENDIX 2................................................................................................................118 DATA ON ADULT MORTALITY PRESENTED BY DR MW MAKGOBA AT THE SECOND MEETING.................................118 APPENDIX 3................................................................................................................126 STATS SA RESPONSE TO THE MEDICAL RESEARCH COUNCIL'S INTERPRETATION OF DEATHS............................126 APPENDIX 4................................................................................................................133 STATS SA REJOINDER TO THE MRC’S RESPONSE....................................................................................134 6 Presidential Aids Advisory Panel Report Acknowledgements The letter from President Thabo Mbeki inviting eminent persons to participate in the Presidential Advisory Panel on AIDS referred to the World Health Organisation report on the 'Global situation of the HIV/AIDS pandemic, end 1999' to describe the gravity of the situation that South Africa and the rest of the world were confronted with. The panel was constituted as part of the government's decision to respond to the AIDS catastrophe in an urgent and comprehensive manner, using all means at its disposal. The invitations went out to eminent scientists and persons from all continents of the world who were expected to bring into the debates all points of view on the issues of HIV and AIDS. The responses to the invitations were instantaneous and reflected the overwhelming desire and determination to assist the South African government as it confronted the challenge posed by AIDS. Within a short period of two weeks, thirty-two (32) of these eminent persons assembled in Pretoria for the first meeting of the panel which took place on 6-7 May 2000. The second meeting of the panel took place in Johannesburg on 3-4 July 2000 and was attended by thirty (30) of the original invitees. Several invitees who could not attend either of the two meetings made their contributions to the debate through the Internet medium that was provided. The panel was further enhanced by fifteen (15) members, mainly South African, who were invited by the Secretariat that supported and facilitated the work of the panel. The response of these invitees was just as overwhelmingly positive as that of the Presidential invitees. The government and the people of South Africa are deeply indebted to these persons who responded without hesitation and in a selfless manner when the clarion call went out. Their generous contributions will undoubtedly prove pivotal as the world grapples with the challenge described in the WHO report referred to in the Presidents letter of invitation. The debate of the complexity that was envisaged could not progress smoothly without expert facilitation. Such facilitation was ably provided by Professor Stephen Owen, Professor Ephraim Mokgokong and Dr Stephen Chandiwana. Their collective performance was a study in patient facilitation as they navigated the panel through complex and at times heated discussions. Great debt is also owed to members of the Secretariat who were ably assisted by officials from the Departments of Health and of Arts, Culture, Science and Technology. Special words of appreciation also go out to the team that produced the first draft of the report as well as the final editors of the report. Individual names of the many people involved in the working of the panel have not been included because the list would be just too long. The government and the people of South Africa are deeply indebted to you all. 7 Presidential Aids Advisory Panel Report Abbreviations ADD AIDS-defining disease AIDS Acquired immune deficiency syndrome AZT Azidothymidine CDC Centers for Disease Control and Prevention CTL Cytotoxic T-lymphocytes CMV Cytomegalovirus DNA Deoxyribonucleic acid EM Electron micrograph HBV Hepatitis B Virus HHSV-VI Human herpes simplex virus 6 HHV Human Herpes Virus HIV Human Immunodeficiency Virus HTLV-II Human T-cell Leukaemia Virus 2 NIAID National Institute of Allergy and Infectious Diseases NIH National Institutes of Health NIV National Institute of Virology OD Optical Density PCR Polymerase chain reaction PEP Post exposure prophylaxis RCT Randomised Controlled Trial RNA Ribonucleic acid SADHS The South African Demographic and Health Survey SAIMR South African Institute of Medical Research SIV Simian Immunodeficiency Virus STD Sexually transmitted disease STI Sexually transmitted infections US(A) United States (of America) WHO World Health Organisation 8 Presidential Aids Advisory Panel Report CHAPTER 1 – SETTING THE SCENE 1.1 Background The South African government is currently confronted with the challenge of responding to the growing AIDS (Acquired Immune Deficiency Syndrome) epidemic. The government’s response has been characterised in the main by a prevention strategy, supported by a multi-sectoral programme involving partnerships between government departments, civil society, NGOs (non-government organisations) as well as other sectors like the women’s sector, faith-based organisations, the youth, traditional healers and traditional leaders. The nature of the AIDS epidemic in South Africa, and sub-Saharan Africa in general, has been a growing cause for concern and recent developments in several areas of the response have created a need to evaluate some of the interventions. It is also an established fact that the determinants of the epidemic and some of the factors that continue to fuel it lie outside the health sector. The strategies adopted by the South African government for an effective response to this challenge have incorporated this reality. Early in 2000, the South African government posed pertinent questions on several key issues relating to this epidemic. Among these were questions relating to the accuracy of the tests currently used to make the diagnosis of human immunodeficiency virus (HIV) infection; the impact of poverty and malnutrition on the ability of people to respond to this infection; and the relationship between HIV infection and many other infections which are common in Africa such as Tuberculosis (TB), malaria, hepatitis as well as other parasitic infections. Discussions among officials of the South African National Department of Health (NDOH), local and international experts in the fields of AIDS and HIV yielded a variety of differing and consensual views on some of the matters. Opinions on some of the pertinent issues were so diverse that it seemed important to interrogate these in an open debate. The South African government became aware of divergent views on the existence, detection and actions of the 'primary' aetiological agent for AIDS, the human immunodeficiency virus (HIV). Theories were being advanced to explain causes of AIDS other than HIV infection. Views were also expressed which doubt the accuracy of the data upon which the extent of the disease in South Africa, as well as globally, is being assessed. In fact, some of these views questioned the authenticity of the claim that an AIDS epidemic exists at all in South Africa. In order to gain a full knowledge of AIDS, a decision was taken to invite an international panel of experts to South Africa and provide a platform for them to deliberate on the issues pertaining to the subject. The report of such deliberations will be used to inform and advise the government as to the most appropriate course of action to follow in dealing with AIDS. This decision was endorsed by the Cabinet of the South African government in April 2000. A world-wide search took place to identify eminent specialists in the fields of AIDS and HIV, ranging in scope from basic scientists, physicians, historians, economists, public health professionals as well as policy makers. It was also decided that persons living with AIDS, as well as lay persons would be invited to serve on the panel. 9 Presidential Aids Advisory Panel Report 1.2 Composition of the Presidential AIDS Advisory Panel Both local and international scientists were invited to form part of the Presidential AIDS Advisory Panel. They were: Invited by the President and were present at both meetings Professor Salim S Abdool-Karim Dr Clifford Lane Dr Stefano M Bertozzi Dr Marsha Lillie-Blanton Dr Harvey Bialy Dr Malegapuru W Makgoba Dr Awa Marie Coll-Seck Professor Sam Mhlongo Dr Etienne de Harven Professor Ephraim Mokgokong Dr Ann Duerr Professor Stephen Owen Professor Peter Duesberg Dr Jorge Perez Dr Christian Fiala Dr David Rasnick Dr Helene Gayle Mr David Scondras Dr Roberto A Giraldo Dr Joseph Sonnabend Dr ET Katabira Dr Zena Stein Dr Claus Koehnlein Dr Gordon Stewart Dr Manu VL Kothari Invited by the President and present only at the first meeting Dr W Chalamira-Nkhoma Dr Mark D Smith Dr Andrew Herxheimer Dr Stefano Vella Proffesor Luc Montagnier Dr Jose M Zuniga Dr Walter Prozesky Invited by the President and present only at the second meeting Dr Stephen Chandiwana Professor Eleni Papadopoulos-Eleopoulos Professor Roy Mugwera Prof Heinz Spranger Dr Valender Turner 10 Presidential Aids Advisory Panel Report

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REPORT. A synthesis report of the deliberations by the panel of experts invited by the President of the Republic of South Africa, the Honourable Mr Thabo Mbeki.
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